Evidence map›Paper›PMID 24916909›Full record

ArticleStroke2014

Can response-adaptive randomization increase participation in acute stroke trials?

Jason S Tehranisa, William J Meurer

Abstract readComparative Study
In one paragraph

Article in Stroke, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Article
  5. Review
  6. Review
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  13. Article
  14. Are outcome-adaptive allocation trials ethical?Clinical trials (London, England) · 2015
    Article
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Jason S TehranisaFrom the University of Michigan Medical School, Ann Arbor (J.S.T.); and Department of Emergency Medicine (W.J.M.) and Department of Neurology (W.J.M.), University of Michigan Health System, Ann Arbor.
William J MeurerFrom the University of Michigan Medical School, Ann Arbor (J.S.T.); and Department of Emergency Medicine (W.J.M.) and Department of Neurology (W.J.M.), University of Michigan Health System, Ann Arbor. wmeurer@med.umich.edu.

Funding

SHORT-TERM TRAINING IN HEALTH PROF SCHOOLST35HL007690 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI FLAHERTY, KEVIN R · 1990 to 2024
$3.3M
NHLBI NIH HHS T35 HL007690
6 · The paper itself

Abstract

background and purposeA response-adaptive randomization (RAR) trial design actively adjusts the ratio of participants assigned to each trial arm, favoring the better performing treatment by using outcome data from participants already in the trial. Compared with a standard clinical trial, an RAR study design has the potential to improve patient participation in acute stroke trials.

methodsThis cross-sectional randomized survey included adult emergency department patients, age≥18, without symptoms of stroke or other critical illness. A standardized protocol was used, and subjects were randomized to either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. A multivariable logistic regression model was fitted to estimate the impact of RAR while controlling for demographic factors and patient understanding of the design.

resultsA total of 418 subjects (210 standard and 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% confidence interval, 3.7-22.2). The RAR group had a higher odds ratio of agreeing to research (odds ratio, 1.89; 95% confidence interval, 1.2-2.9) while adjusting for patient level factors. Trial designs were generally well understood by the participants.

conclusionsThe hypothetical RAR trial attracted more research participation than standard randomization. RAR has the potential to increase recruitment and offer benefit to future trial participants.

Indexed as

Informed ConsentRandomized Controlled Trials as TopicResearch DesignStrokeAdultCross-Sectional StudiesHumansPatient Participationcerebrovascular accident, acuteemergency medicinestroke, acutetissue plasminogen activator

Identifiers

PMID24916909
PMCPMC4081030

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.